Suppliers / Benechim

Benechim

Belgium Updated 9 July 2026

Benechim is an API manufacturer based in Belgium. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 February 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 February 2025 VAI US FDA
  • 26 January 2021 VAI US FDA
  • 5 February 2016 VAI US FDA
  • 21 June 2013 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Belgium, Belgium 3004293182

What they file, and where

Molecule Regulators Docs
Articaine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Articaine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Benechim

Is Benechim FDA-registered?
One site operated by Benechim carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Benechim's last inspection go?
The most recent inspection on record closed on 10 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Benechim manufacture?
1 registered site is on record, in Belgium (Belgium). Every site is listed on this page with the register it came from.
What does Benechim make?
1 molecule is on record against Benechim, including Articaine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Benechim's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 10 February 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates